“Pharmaceutical, biotech and medical device companies are increasingly looking for technologies to gather more and better patient data. However, a key concern is the increasing burden on investigative sites, currently tasked with using disparate systems for different clinical trials in addition to the systems needed to manage their medical practices and record data from patients who are not participating in research studies,” said Medidata’s President Glen de Vries. “The rapidly expanding ecosystem of EMR, EHR and eSource technologies requires openness and interoperability, which our eConnect program provides by making it possible to integrate them all with the industry-leading electronic data capture capability on our platform. This will enable clinical trial sponsors to simplify day-to-day operations and workflows at investigative sites through a single system that’s already in place, eliminating the need for staff to repeatedly enter the same data in multiple systems and resolve transcription errors.”

According to a May 2016 CenterWatch report conducted in partnership with the Association of Clinical Research Professionals (ACRP), investigative sites typically use an average of 10 different systems to collect data for clinical trials. Study coordinators and investigators who were surveyed noted that using incompatible systems results in increased workloads for sites, greater operational inefficiencies and lower productivity.

A key example cited is the lack of integration between EHRs, EMRs and other eSource systems—used by clinicians to record patient data—and EDC (electronic data capture) systems—administered by sponsors and CROs. The phenomenon has perpetuated a cumbersome double-data entry practice commonly referred to as “swivel chair interoperability,” which creates significant delays in collecting and cleaning data.

Through eConnect, Medidata is providing the global life sciences industry with a program to overcome these issues. Clinical Ink, Clinical Research IO, Foundry Health and BreezeCTMS are among the eSource providers who have already joined the program. Using Medidata’s Rave Web Services API and the Medidata platform’s single sign-on capabilities, eConnect partners will be able to create solutions to connect their systems to the Medidata Clinical Cloud. This will allow investigative sites to use one system—their primary clinical record—for all research efforts, regardless of which clinical trial sponsor or CRO is conducting the study.

“eConnect is the first commercially available program to alleviate ‘swivel chair interoperability,’ no matter what type of eSource system clinical trial sites use—whether it’s their own, a sponsor-provided technology or an EHR or EMR integration,” de Vries added. “The flexibility our program provides will make it easier for sponsors to work with investigative sites that have the right therapeutic expertise while supporting broader efforts to drive their long-term retention in clinical research programs.”

In facilitating the use of eSource data for clinical research, the eConnect Partner Program will also support the industry’s broader efforts to increase adoption of data standards, such as those established by the Clinical Data Interchange Standards Consortium (CDISC), a nonprofit organization dedicated to streamlining and automating R&D processes.

“It’s gratifying to see Medidata, a long-term member of CDISC, launch a program that aligns with the broad goals of eSource: bringing together the worlds of healthcare and clinical research to enable better efficiencies and better quality data,” said Michael Ibara, CDISC’s head of digital healthcare. “The potential benefits of an end-to-end, interoperable approach for both sites and researchers are numerous, whether we’re talking about eliminating data duplication and transcription errors, producing more accurate and complete data, providing more timely access to EHR data from clinical sources, or reducing travel costs for data monitors by making it possible for them to access computerized data remotely. These factors could encourage more doctors to participate in clinical research and, in the long run, contribute to therapeutic advances.”

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